Catalog Number

DI-7101

Brand Name

Coulmed Products Group

Version/Model Number

DI-7101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

7eb9929c-d904-4c92-9628-c82c2d1ac8bf

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

October 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-